Acne Vulgaris

• FDA approval · 2014-07-01
  FDA Approved: EPIDUO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for Epiduo (adapalene and benzoyl peroxide) by Galderma Laboratories, L.P., updating its labeling.

• FDA approval · 2014-06-13
  FDA Approved: ADAPALENE — Supplemental Application (Mayne Pharma Commercial LLC.)

  FDA approved a supplemental application for adapalene submitted by Mayne Pharma Commercial LLC.

• FDA approval · 2014-03-05
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic doxycycline (DOXYCYCLINE) under an original application.

• FDA approval · 2014-02-28
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC.

• FDA approval · 2014-01-29
  FDA Approved: RETIN-A MICRO — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for RETIN-A MICRO (tretinoin) from Bausch Health US LLC.

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• FDA approval · 2014-01-28
  FDA Approved: RETIN-A MICRO — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for RETIN-A MICRO (tretinoin) from Bausch Health US LLC.

• FDA approval · 2013-12-13
  FDA Approved: TAZORAC — Supplemental Application (Almirall, LLC)

  The FDA approved a supplemental application for TAZORAC (tazarotene) filed by Almirall, LLC.

• FDA approval · 2013-08-20
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  FDA has approved a supplemental application for ZIANA from Bausch Health US, LLC, involving the combination of clindamycin phosphate and tre…

• FDA approval · 2013-08-02
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  FDA approves a supplemental application for ZIANA (clindamycin phosphate and tretinoin) from Bausch Health US, LLC to update its label for a…

• FDA approval · 2013-07-02
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ZIANA (clindamycin phosphate and tretinoin) from Bausch Health US, LLC. The action reflects a su…

• FDA approval · 2013-05-14
  FDA Approved: RETIN-A — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for RETIN-A (tretinoin) submitted by Bausch Health US, LLC.

• FDA approval · 2013-03-25
  FDA Approved: ZENATANE — Original Application (BluePoint Laboratories)

  FDA approved ZENATANE (isotretinoin) from BluePoint Laboratories under its original application (ANDA 202099). It is indicated for the treat…

• FDA approval · 2013-03-04
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for ZIANA (clindamycin phosphate and tretinoin) submitted by Bausch Health US, LLC.

• FDA approval · 2013-02-15
  FDA Approved: EPIDUO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for EPIDUO (adapalene and benzoyl peroxide) submitted by Galderma Laboratories, L.P.

• FDA approval · 2013-02-01
  FDA Approved: EPIDUO — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for Epiduo, the acne medication combining adapalene and benzoyl peroxide, submitted by Galderma …

• FDA approval · 2013-01-08
  FDA Approved: RETIN-A MICRO — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for RETIN-A MICRO (tretinoin) submitted by Bausch Health US LLC.

• FDA approval · 2012-12-18
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for Acanya (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC, updating the…

• FDA approval · 2012-10-24
  FDA Approved: TRETINOIN — Original Application (Endo USA, Inc.)

  FDA approved tretinoin as a generic product under an Original Application from Endo USA, Inc.

• FDA approval · 2012-06-26
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an original application for a generic product combining clindamycin phosphate and benzoyl peroxide for topical treatment of acn…

• FDA approval · 2012-06-14
  FDA Approved: ADAPALENE GEL USP, 0.3% — Original Application (Encube Ethicals, Inc.)

  FDA approved adapalene gel 0.3% as a generic product (ANDA) submitted by Encube Ethicals, Inc.

• FDA approval · 2012-05-25
  FDA Approved: ABSORICA — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved ABSORICA (isotretinoin) from Sun Pharmaceutical Industries under an original application. It is indicated for severe, recalcitr…

• FDA approval · 2012-05-11
  FDA Approved: TAZAROTENE — Original Application (Mayne Pharma Inc.)

  The FDA approved Mayne Pharma's original application for tazarotene, a topical retinoid, for dermatologic use.

• FDA approval · 2012-04-30
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin filed by Mayne Pharma.

• FDA approval · 2012-04-25
  FDA Approved: DOXYCYCLINE HYCLATE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  The FDA approved a supplemental application for doxycycline hyclate from Chartwell Governmental & Specialty RX, LLC, confirming regulatory s…

• FDA approval · 2012-04-12
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a Supplemental Application for CLARAVIS (isotretinoin) submitted by Teva Pharmaceuticals USA, Inc.